drugset / Trial / NCT01034995
A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder
RandomizedParallel-groupTriple-blindTreatment
Summary
Primary Objective: * To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. Secondary Objectives: * To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder * To evaluate plasma concentrations of SSR125543
Timeline
- Start
- 2010-02
- Primary completion
- 2011-03
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crinecerfont | Small molecule | 20 mg | Oral |
| Subject | Crinecerfont | Small molecule | 50 mg | Oral |
| Subject | Crinecerfont | Small molecule | 100 mg | Oral |
| Comparator | Escitalopram | Small molecule | 10 mg | Oral |